Fluarix

A prospective pilot study, with two groups of 10 participants each, was conducted at the Hope Clinic of the Emory Vaccine Center during the 2018–2019 influenza season. The H3N2 group (n = 10) consisted of healthy participants born between 1968–1977, when H3N2 was the primary IAV circulating in the US. The H1N1 group (n = 10) consisted of participants born between 1948 and 1957, when H1N1 was the primary IAV circulating in the US. Each group was further stratified by participants who received the seasonal influenza vaccine two times or less in the past five seasons, and participants who received the influenza vaccine three or more times in the past five seasons. Once informed consent was obtained, study procedures were performed and subjects were followed for a period of 6 months. Baseline phlebotomy was obtained on Day 1, followed by intramuscular administration of the FDA approved 2018–2019 quadrivalent influenza vaccine (one 0.5 mL dose to the deltoid muscle lot number 75TA2, Fluarix, GSK, Brentford, UK) between October 2018 and January 2019. The components of the vaccine are listed (Table 1). Subsequent study visits occurred on Days 3, 8, 15, 29, and 180. The study was approved by the Institutional Review Board of Emory University (9/17/2018).

GlaxoSmithKline (GSK) provided the IIV split virus vaccines, which were described previously [31 (link),33 (link)]. All IIV vaccines used in this preclinical study were adjuvanted with Adjuvant System 03 (AS03) as described in our previous studies [31 (link),33 (link),39 (link)]. The cH8/1 and cH11/1 LAIVs were reported previously [31 (link),33 (link)]. The recombinant influenza B virus expressing cH9/1 virus (B-cH9/1) was as previously described [40 (link)]. The quadrivalent inactivated influenza vaccine (QIV), Fluarix, was produced by GSK and it contained the 2016/17 formulation with the strains A/Christchurch/16/2010 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.

Breast cancer cell lines 4T1 and MDA-MB-231 were procured from the American Type Culture Collection (ATCC, Manassas, VA, USA). Cells were thawed, centrifuged, and expanded in recommended culture media as directed by the manufacturer, then cryopreserved for later expansion and further use. Cells were then cultured in RPMI 1640 medium with L-glutamine and supplemented with 10% fetal bovine serum (FBS) at 37 °C in a humidified atmosphere containing 5% CO₂. The influenza vaccine (FluVax) used for the study was the 2020/2021 season FLUARIX, manufactured by GlaxoSmithKline Biologicals (Dresden, Germany) and stored at 4 °C until use.

Participants were vaccinated according to the guidelines for seasonal influenza from the Danish Health Authority and the Danish Paediatric Society, which recommend vaccination to risk groups [12 , 13 ]. Children aged 6 months to 8 years not previously vaccinated against influenza were vaccinated twice with an interval of at least 4 weeks. Children aged 9 years and above, and children previously vaccinated against influenza, were only vaccinated once. The injection was administered intramuscularly in the deltoid.
The vaccines used were: Fluarix®, GlaxoSmithKline, Australia or Vaxigrip®, Sanofi, France. According to the WHO recommendation for the northern hemisphere in 2015–2016 the vaccines included A/California/07/2009-like (H1N1)pdm09 (A/Cal H1N1pdm09); A/Switzerland/9,715,293/2013-like (H3N2) (A/Swi H3N2); and B/Phuket/3073/2013-like (Yamagata-lineage) (B/Phu Yamagata) [14 ].